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Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial

Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial
Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial
Background. Reducing antibiotic use for upper respiratory infections (URTIs) is needed to limit the global threat of antibiotic resistance. Our aim was to estimate the effectiveness of probiotics and xylitol which could plausibly improve the management of pharyngitis.

Methods. This was a parallel group factorial randomised controlled trial. Participants in primary care aged 3 and over with pharyngitis were randomised by nurses providing sequential intervention packs. Pack contents for three kinds of material/advice were previously determined by computer generated random numbers: a) no chewing gum b) xylitol based chewing gum (15% xylitol; 5 pieces/day) and c) sorbitol gum (5 pieces/day). Half of each group were also randomised to receive either probiotic capsules (containing 25x109 colony forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was the self-reported mean severity of sore throat and difficulty swallowing (0-7 scale) in the first 3 days. Multiple imputation avoided assuming data was missing completely at random.

Results. 1009 individuals consented, 934 completed baseline assessment, and 689 provided complete primary outcome data. Probiotics were not effective (No probiotic mean severity score 2.75, Probiotic 2.78, adjusted difference -0.001 (95% confidence intervals -0.24 to 0.24, p=1.00), neither was chewing either sorbitol (no gum 2.73, sorbitol 2.72 (difference 0.07, -0.23 to 0.37, p=0.65) or xylitol 2.73 (difference vs no gum 0.01, -0.29 to 0.30 p=0.96). No secondary outcomes were significantly different between groups, and no harms were reported.

Interpretation. Neither probiotics nor advice to chew xylitol-based chewing gum are effective for the management of pharyngitis.
0820-3946
E1543-E1550
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Stuart, Beth
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Wingrove, Zoe
fb3b9a7d-0b49-4ffe-be46-f3d4e6c6af22
Mullee, Mark
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Thomas, Tammy
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Johnson, Sophie
9919c64a-b60b-4371-81bc-9540db19a56b
Leydon, Geraldine
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Richards-Hall, Samantha
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Williamson, Ian
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Yao, Lily
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Zhu, Shihua
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Moore, Michael
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Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Stuart, Beth
626862fc-892b-4f6d-9cbb-7a8d7172b209
Wingrove, Zoe
fb3b9a7d-0b49-4ffe-be46-f3d4e6c6af22
Mullee, Mark
fd3f91c3-5e95-4f56-8d73-260824eeb362
Thomas, Tammy
742fc3b2-61cb-4f87-8466-afa31b3c8d8e
Johnson, Sophie
9919c64a-b60b-4371-81bc-9540db19a56b
Leydon, Geraldine
c5cdaff5-0fa1-4d38-b575-b97c2892ec40
Richards-Hall, Samantha
dec677d7-b6a7-4e99-b10e-c1e22b3055cf
Williamson, Ian
12381296-edbf-4ac5-969b-dcb559c22f27
Yao, Lily
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Zhu, Shihua
13511f9c-151c-483c-9dfd-2da13421db5c
Moore, Michael
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Little, Paul, Stuart, Beth, Wingrove, Zoe, Mullee, Mark, Thomas, Tammy, Johnson, Sophie, Leydon, Geraldine, Richards-Hall, Samantha, Williamson, Ian, Yao, Lily, Zhu, Shihua and Moore, Michael (2017) Probiotic capsules and xylitol chewing gum to manage symptoms of pharyngitis: a randomized controlled factorial trial. Canadian Medical Association Journal, 189 (50), E1543-E1550. (doi:10.1503/cmaj.170599).

Record type: Article

Abstract

Background. Reducing antibiotic use for upper respiratory infections (URTIs) is needed to limit the global threat of antibiotic resistance. Our aim was to estimate the effectiveness of probiotics and xylitol which could plausibly improve the management of pharyngitis.

Methods. This was a parallel group factorial randomised controlled trial. Participants in primary care aged 3 and over with pharyngitis were randomised by nurses providing sequential intervention packs. Pack contents for three kinds of material/advice were previously determined by computer generated random numbers: a) no chewing gum b) xylitol based chewing gum (15% xylitol; 5 pieces/day) and c) sorbitol gum (5 pieces/day). Half of each group were also randomised to receive either probiotic capsules (containing 25x109 colony forming units of lactobacilli and bifidobacteria) or placebo. The primary outcome was the self-reported mean severity of sore throat and difficulty swallowing (0-7 scale) in the first 3 days. Multiple imputation avoided assuming data was missing completely at random.

Results. 1009 individuals consented, 934 completed baseline assessment, and 689 provided complete primary outcome data. Probiotics were not effective (No probiotic mean severity score 2.75, Probiotic 2.78, adjusted difference -0.001 (95% confidence intervals -0.24 to 0.24, p=1.00), neither was chewing either sorbitol (no gum 2.73, sorbitol 2.72 (difference 0.07, -0.23 to 0.37, p=0.65) or xylitol 2.73 (difference vs no gum 0.01, -0.29 to 0.30 p=0.96). No secondary outcomes were significantly different between groups, and no harms were reported.

Interpretation. Neither probiotics nor advice to chew xylitol-based chewing gum are effective for the management of pharyngitis.

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Accepted/In Press date: 22 August 2017
e-pub ahead of print date: 18 December 2017

Identifiers

Local EPrints ID: 413447
URI: http://eprints.soton.ac.uk/id/eprint/413447
ISSN: 0820-3946
PURE UUID: 86d4daa3-b58b-4b0c-9d00-e751d5033272
ORCID for Beth Stuart: ORCID iD orcid.org/0000-0001-5432-7437
ORCID for Geraldine Leydon: ORCID iD orcid.org/0000-0001-5986-3300
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 24 Aug 2017 16:30
Last modified: 18 Feb 2021 17:07

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Contributors

Author: Paul Little
Author: Beth Stuart ORCID iD
Author: Zoe Wingrove
Author: Mark Mullee
Author: Tammy Thomas
Author: Sophie Johnson
Author: Samantha Richards-Hall
Author: Ian Williamson
Author: Lily Yao
Author: Shihua Zhu
Author: Michael Moore ORCID iD

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